SOLICITATION NOTICE
A -- Recipient Epidemiology and Donor Evaluation Study III (REDS-III)
- Notice Date
- 6/27/2016
- 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
- HHS-NIH-NHLBI-16-28
- Point of Contact
- Kelli Malkin, , Allison M Cristman, Phone: 301-435-0359
- E-Mail Address
-
Kelli.Malkin@nih.gov, allison.cristman@nih.gov
(Kelli.Malkin@nih.gov, allison.cristman@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- INTRODUCTION THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A CONTRACT MODIFICATION WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME). The National Heart, Lung, and Blood Institute (NHLBI), Office of Acquisitions (OA) intends to negotiate and award a contract modification without providing for full and open competition (including brand-name) to each of the following contractors for the Recipient Epidemiology and Donor Evaluation Study III (REDS-III) program: 1) Research Triangle Institute (Contract No. HHSN268201100002I) 2) BloodCenter of Wisconsin (Contract No. HHSN268201100003I) 3) Institute for Transfusion Medicine (Contract No. HHSN268201100004I) 4) The Regents of the University of California (Contract No. HHSN268201100005I) 5) Yale University (Contract HHSN268201100006I) 6) Brazil - Blood Systems Inc dba Blood Systems Research Institute (Contract No. HHSN268201100007I) 7) China - Johns Hopkins University (Contract No. HHSN268201100008I) 8) South Africa - The Regents of the University of California (Contract No. HHSN268201100009I) REGULATORY AUTHORITY The resultant contract modifications will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 05-88-1, June 15, 2016. This acquisition is conducted under the procedures as prescribed in FAR subpart 15-Contracting by Negotiation at an amount exceeding the simplified acquisition threshold ($150,000). STATUTORY AUTHORITY This acquisition is conducted under the authority of 41 U.S.C. 253(c) under provisions of the statutory authority of FAR Subpart 6.302-1 - Only one responsible source and no other supplies or services will satisfy agency requirements 41 U.S.C. 253(c)(1). BACKGROUND The incumbent contracts listed above are for the Data Coordinating Center, four Domestic Hubs, and three International collaborative sites of the Recipient Epidemiology and Donor Evaluation Study III (REDS-III) program. 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. PURPOSE, CONTRACT STRUCTURE, AND PERIOD OF PERFORMANCE The proposed action is a modification to each of the eight existing single award Indefinite Delivery, Indefinite Quantity (IDIQ) contracts, each with cost-reimbursement task orders. The modifications will revise the Statement of Work to include analytical/statistical support for the Recipient Epidemiology and Donor Evaluation Study III (REDS-III) Domestic Hubs and International Sites during the course of program. The Statement of work of the Data Coordinating Center will also be revised to allow the other REDS III contractors to provide analytical/statistical support when specified by the Contracting Officer's Representative. The modifications do not obligate any funds; funds are obligated under task orders that are issued against the base IDIQ contract. MANDATORY QUALIFICATION CRITERIA Listed below are mandatory qualification criteria for a successful offeror. The qualification criteria establish conditions that must be met at the time of receipt of responses by the Contracting Officer in order to be responsive to the requirement. Domestic Hubs: a. The hub shall be structured to consist 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: 1) intensive care unit(s); 2) cardiac surgery; 3) orthopedic surgery; 4) oncology/cancer center; and 5) trauma services. b. To ensure the statistical relevance of the resulting data, the hub 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. International Collaborative Sites: 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 The parent contracts Statement of Work will be revised to include analytical/statistical support in the contracts for the REDS III Domestic Hubs and International Sites, and to revise the Statement of the Data Coordinating Center to allow the other REDS III contractors to provide the analytical/statistical support. The Data Coordinating Center, four Domestic Hubs, and three International Sites are expected to provide the necessary technical expertise and facilities to effectively perform the tasks and meet the requirements identified below: Data Coordinating Center: 1. Coordinate REDS-III activities and participate as a member of the Steering Committees to develop and implement a coordinated plan to achieve program objectives. The Contractor shall facilitate and be responsible for the scheduling, planning, and administration of meetings and conference calls for the REDS-III program and shall assist when necessary with other administrative activities involving the central laboratory, domestic sites and international sites. The Principal Investigator for the data coordinating center shall attend the Domestic Steering Committee and each of the International Steering Committee meetings that are held in the U.S.; and shall be a voting member for each of these Committees. The Contractor shall arrange for Steering Committee and subcommittee meetings/conference calls and other key meetings/conference calls as needed; prepare agendas in coordination with the committee chair and NHLBI; prepare and distribute review materials for the meetings/calls; and take and distribute minutes of the meetings/calls for review and approval by the NHLBI Contracting Officer's Representative(s) within 20 working days of the meeting/call. The Contractor shall track and maintain a central repository of minutes and materials relating to the functioning of the various committees on the private REDS-III website and inform REDSIII participants when minutes and materials are posted. The Contractor shall provide funding and logistical support for the Steering Committee External Chair. The External Chair shall be selected by the NHLBI Contracting Officer's Representative(s). 2. Maintain Operating Procedures for the REDS-III program. The Contractor shall revise and update the Operating Procedures developed in Phase 1 of the REDS-III contract in collaboration with the REDS-III Oversight Committee and NHLBI staff to meet the growing and changing needs of the contract throughout the contract period. Revisions to the Operating Procedures shall be posted within five (5) business days of approval by NHLBI. 3. Maintain a public and private REDS-III website. The Contractor shall, in collaboration with the Steering Committees and NHLBI, maintain an interactive, secure, scalable and robust web-based information and administrative platform that was developed in Phase 1 of the REDS-III contract. The platform design shall be flexible to meet changing needs of the REDS-III program and shall facilitate communications between REDS-III participants. The Contractor shall provide a secure environment and the necessary data management system(s) and informatics support to acquire, store, catalogue, query, and distribute documents and materials required for the successful performance of the program. The private website shall contain all information pertaining to REDS-III activities and serve as a communication portal for the program. Examples of documents include but are not limited to protocols, Operating Procedures, Manuals of Operations, case report forms, Steering Committee minutes, presentations and manuscripts. The public website shall include a description of the REDS-III program and its objectives, a list of participants, a summary of the REDS-III research studies, a list of REDS-III publications, contact information, and other information of interest to the general public. All information and documentation developed for the public website shall be reviewed and approved by the Steering Committees and NHLBI before being posted on the public website. The computer programs, databases, and other resources developed through this contract shall be compliant with terminology and data standards established by NHLBI. The Contractor shall ensure that the REDS-III computer hardware and software procedures comply with all Federal and State regulations. 4. Provide all necessary data management and tracking systems. The Contractor shall develop and implement secure and robust data collection, tracking, management, and storage procedures for all data compiled by the REDS-III program. The Contractor shall provide all necessary data management systems to the central laboratory, domestic hubs, and, as appropriate, to the international collaborative programs. In particular, the contractor shall provide a web-based data entry system to the domestic hubs. The Contractor shall perform all activities of a coordinating center such as collecting, organizing and storing data from the central laboratory, domestic hubs, and international collaborative programs. The Contractor shall assure the quality of the study data submitted and stored. The Contractor shall provide a Data Management Plan, a Data Quality Control/Quality Assurance Plan, and a Data Security Plan to be included in the REDS-III Operating Procedures. The computer programs, data management systems, databases, and other resources developed through this contract shall be compliant with terminology and data standards established by NHLBI. The Contractor shall ensure that the REDS-III computer hardware and software procedures comply with all Federal and State regulations. All data shall be entered and transmitted to the DCC by the domestic hubs, the international collaborative programs, and by the central laboratory. The DCC shall provide all necessary data management system(s). Data to be collected, managed, and analyzed shall include donation infectious disease marker data, donor demographic and other data; cross-matched patient demographic, clinical, and laboratory data; study-specific data; and data from the central laboratory. For the domestic program, data on patients that were considered for transfusion and/or transfused while admitted at participating hospital services are to be extracted from medical records and entered routinely by the domestic hubs in a web-based data entry system provided by the data coordinating center. The DCC shall compile domestic hubs' data in 1) a centralized cumulative donor/donation/component database; 2) a centralized cumulative patient database; and 3) a 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 aim is to include in this database comprehensive data on at least 85% of donations whose products have been transfused to patients at each hub. For each international program, the U.S.-based institution shall manage the international centers' scope of work and study protocols, and ensure transmission of complete and accurate scientific data from the foreign blood collection sites to the REDS-III DCC. Each international program shall collect, prepare and provide data on a total of at least 250,000 donations annually with corresponding donor information to the DCC. The DCC shall compile international centers' data in a centralized cumulative donor/donation database (one for each international program). 5. Track all REDS-III biospecimens and their associated data, and identify biospecimens for retrieval. The Contractor shall, in coordination with the central laboratory, provide a biospecimen tracking system and maintain access to an inventory of biospecimens collected by the REDS-III program as well as their associated phenotypic and/or genotypic characteristics. The Contractor shall track shipment of biospecimens from centers to the REDS-III central laboratory or to other testing and/or storage facilities. The Contractor shall track all biospecimen data including collection dates, processing characteristics, and phenotypic and/or genotypic characteristics. The Contractor shall be able to access the biospecimen inventory and provide lists of biospecimens with particular characteristics to the central laboratory or other testing/storage facility for retrieval and further testing, per protocol specifications. The Contractor shall obtain and compile all laboratory data obtained on biospecimens in datasets for subsequent interpretation and statistical analysis. 6. Analyze database and study data collected during REDS-III. The Contractor's statistical and analytical capabilities shall include the ability to conduct simple and complex analyses of data from descriptive studies, case control studies, cohort studies, complex survey design studies, laboratory studies, and intervention studies. 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 analyses may be needed when a gold standard does not exist. The Contractor shall provide the necessary statistical programming expertise as well as the necessary statistical software(s) to conduct simple as well as complex, and sometimes novel analyses. 7. Assist the Steering Committees in preparation of scientific reports for publication and presentation. The Contractor shall participate in the development of scientific abstracts, presentations and publications; coordinate Publications Committees, and other relevant subcommittees' calls; check all data for accuracy; and post on the website all REDS-III presentations and publications. 8. Coordinate and convene the REDS-III Observational Study Monitoring Board (OSMB). As requested by the Contracting Officer's Representative(s), the Contractor shall provide administrative and logistic support for OSMB meetings/calls; prepare and present data reports during the open and closed sessions of the OSMB; and prepare minutes of the open and closed sessions. The Contractor shall coordinate and pay for OSMB members travel, conference calls, and honoraria. 9. Interact with the Contracting Officer's Representative(s) on programmatic research activity issues. 10. At close out of the study, or earlier as directed by the Contracting Officer's Representative(s), create public use data sets for each data collection activity with documentation. The Contractor shall transform the REDS-III centralized databases and study-specific datasets into public use datasets that shall be delivered with associated detailed documentation to NHLBI and shall be made available to the scientific community following completion of the contract, or earlier as directed by the Contracting Officer's Representative(s). These datasets shall exclude individual detailed information and shall be appropriate for independent use by an investigator external to the study and unfamiliar with details of the data. 11. Ensure an orderly transition of REDS-III resources to a successor contractor at contract expiration. Sixty (60) calendar days prior to completion of this contract, the Contractor shall provide a transition plan for contract closure and/or transition to a new contractor. The Contractor shall develop this plan in collaboration with the Contracting Officer and the Contracting Officer's Representative(s). The plan shall provide for delivery of appropriate contract materials including data sets/files, databases, files, documents, draft manuscripts, etc. Specifically, the Contractor shall:  Ensure that any manuals, databases and directories developed by the Contractor are accurate and current, and provision is made for the orderly transfer of these materials to the new contractor or the Federal Government, together with complete documentation needed to understand their content, operation and maintenance.  Transfer all contract-developed or government-acquired publications, reprints, abstracts and other documents, results of searches, databases, and necessary files to the new contractor or the Federal Government.  Carry on operations at appropriate staffing levels until the designated transition period has ended. At the request of the Contracting Officer's Representative(s), specific tasks will be relinquished by the current contractor during the transition period. Domestic Hubs: 1. The hub Principal Investigator shall serve as a member of the REDS-III Oversight Committee. As a member of the Oversight Committee, actively collaborate and 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 objectives of the REDS-III program are being met. 2. The hub Principal Investigator and Co-Principal Investigator shall serve as voting members of the REDS-III Domestic Steering Committee. As members of the Domestic Steering Committee (and its subcommittees, as appropriate), serve as active participants in developing and prioritizing all REDS-III domestic research activities, in overseeing and ensuring the progress of ongoing studies, and in developing, reviewing and approving analyses, presentations, and publications. Collaborate with other hubs to develop a REDS-III domestic program portfolio that will advance transfusion medicine. 3. The hub shall participate in, coordinate, and successfully conduct the REDS-III research protocols that have been approved by the REDS-III Domestic Steering Committee. Performance shall be in accordance with study protocols. Provide strong, proactive leadership in dealing with all required hospital services, outpatient services (as appropriate), and the blood center to ensure successful conduct of all research protocols. Coordinate research efforts across hub participants. Obtain all necessary administrative and regulatory clearances. Adhere to all relevant provisions of the Health Insurance Portability and Accountability Act (HIPAA). Incorporate study protocols into blood center/hospital's operations as needed. Contact and enroll participants in study protocols, conduct blood/medical 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 using a data management system provided by the DCC. 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 REDSIII DCC. 4. The hub shall serve as a Centralized Data Collection Center (CCC). The CCC shall be responsible for obtaining and transmitting donor/donation/component and patient data to the DCC. Obtain all necessary administrative and regulatory clearances. Adhere to all relevant provisions of the Health Insurance Portability and Accountability Act (HIPAA). All hub CCCs shall capture the same donor/donation/component and patient data elements as defined by the Domestic Steering Committee and described in the REDS-III Operating Procedures and Manuals of Operations using a data management system provided to each hub by the DCC. The CCC shall also conduct quality-checks on the data. The CCC shall be responsible for collecting all hub data, transmitting the data to the DCC, and providing the necessary IT and data management expertise to: a. Conduct quality-checks on the donor/donation/component data files provided by the participating blood center and by additional blood suppliers or by large blood collection systems, if proposed; and collect additional information on the processing of components that may have occurred at the transfusion service/hospital before infusion into recipients. Donor/donation/component data are comprehensive. Data shall include information on all donations collected at the participating blood center(s) including information on non-transfused and transfused donations and their components, some of which are supplied to the hub's participating hospitals. Data shall not include identifying information such as donor's name, social security number, address, etc. but shall include a unique study identification number (ID) for each donor with each donation record, allowing the donor to be longitudinally followed and their individual donations and components identified in the central databases that shall be maintained by the DCC. Data must include screening and confirmatory test results, demographic information, component manufacturing and processing information, and other information as determined by the Domestic Steering Committee. The files including donation/donor/component data are to be provided by the CCC to the DCC in an electronic format in a timely manner for compilation into a central database and for analysis. This information shall be considered a deliverable to the DCC at specified intervals. b. Collect and enter data on patients that were transfused as well as those considered for transfusion i.e., cross-matched while admitted at participating hospital services (intensive care unit(s), cardiac surgery, orthopedic surgery, oncology/cancer center, and trauma services) and outpatient services, as appropriate. These data shall be retrospectively collected without identifying information (such as name, social security number, address, etc.) on cross-matched adult patients as specified by the REDS-III Domestic Steering Committee. These data shall include demographics, product attributes, primary and secondary diagnoses, primary clinical outcomes, length of stay, clinical, laboratory, and radiological parameters (pre and post transfusion), and adverse events such as transfusion-associated events, re-operation, myocardial infarction, etc. The data shall be extracted from medical records and entered routinely by the CCC in a web-based data entry system to be provided by the DCC. Use of electronic medical record data capture systems is strongly encouraged, whenever available. This information shall be considered a deliverable to the DCC. The hub CCC shall provide a unique study identification number for each patient that shall allow tracking of all information related to the patient when admitted to participating hospitals or seen at participating outpatient clinics. The hospitals shall maintain the link between the unique study patient ID and the medical record patient identifier to allow the hospital to contact the patient for appropriate follow-up. The link between patient identification number and patient name or other identifier shall be kept in a secured location by the research staff at the participating hospital. c. Collect and enter donor (donations/components) and/or patient data for a particular REDS-III study protocol. 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 provided by the DCC as specified in the protocol, and transmitted to the DCC. This information shall be considered a deliverable to the DCC. d. Implement procedures to maintain data security and confidentiality. 5. The hub shall 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; providing evidence-based scientific information for policy development; and developing evidence-based guidelines and knowledge about established and evolving basic biologic and clinical sciences and pathologic correlation, and the application of this information to ensure appropriate care of patients. 6. The hub shall 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. 7. The hub shall adhere to all relevant provisions of the Health Insurance Portability and Accountability Act (HIPAA) and obtain IRB(s) approval(s) for all hub activities described in the REDS-III Operation Procedures, Protocols, Manuals of Operations and any amendments thereto, and for any activities related to closure of datasets and studies. International Collaborative Sites: 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. CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATION The determination by the Government to award these contract modifications without providing for full and open competition is based upon the market research in accordance with FAR 5.202(a)(11). The proposed contract action is made under the terms of existing contracts that were previously synopsized in sufficient detail to comply with the requirements of FAR 5.207 with respect to the current proposed contract action. The incumbent contractors listed under the Background section above were each awarded a contract based on full and open competition under Solicitation Nos. NHLBI-HB-11-02, NHLBI-HB-11-03, and NHLBI-HB-11-04. Full source selection procedures were followed during pre-award activities, including conduct of a peer review and a secondary review of the proposals submitted, discussions with the offerors regarding the technical and cost proposals, and past performance evaluation. The contracts were awarded in March 2011. The contractors have been successfully performing as the Data Coordinating Center, Domestic Hubs, and International Sites for over five years under Task Orders 1 and 2 under their respective contracts. CLOSING STATEMENT This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. Responses to this notice shall contain sufficient information to establish the interested party's bona-fide capabilities for fulfilling the requirement, addressing each project requirement separately. The response should also 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; 4) any other information considered relevant to this program; and 5) the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov. A determination by the Government not to compete this proposed contract modification based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement. All responses must be received by the closing date on this notice and must reference the solicitation number. Responses may be submitted electronically to Kelli Malkin at kelli.malkin@nih.gov, or by U.S. mail to the National Heart, Lung, and Blood Institute, Office of Acquisitions, Extramural Contracts Branch, 6701 Rockledge Drive, Suite 6100, Bethesda, MD 20892-7902, Attention: Kelli Malkin. Fax responses will not be accepted.
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