SOURCES SOUGHT
A -- Recipient Epidemiology and Donor Evaluation Study III (REDS-III) – Data Coordinating Center
- Notice Date
- 12/30/2014
- 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
- HHS-NIH-NHLBI-SBSS-HB-15-09
- 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
- This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses, HUBZone small businesses, service-disabled, veteran-owned small businesses, 8(a) small businesses, veteran-owned small businesses, woman-owned small businesses, or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. The NAICS code for this acquisition is 541712. BACKGROUND The National Heart, Lung, and Blood Institute (NHLBI) is seeking a Data Coordinating Center (DCC) 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 DCC 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. PROJECT REQUIREMENTS During the period from September 15, 2017 - March 14, 2020, the Data Coordinating Center (DCC) is expected to provide the necessary technical expertise and facilities to effectively perform the tasks and meet the requirements identified below: 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. OTHER IMPORTANT CONSIDERATIONS The Government intends to negotiate (1) cost reimbursement task order for the period of September 15, 2017 - March 14, 2020. CAPABILITY STATEMENT - HOW TO SUBMIT A RESPONSE Small businesses 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 project requirement separately. Additionally, the capability statement should include 1) the total number of employees; 2) the professional qualifications of scientists, medical experts, and technical personnel as it relates to the above outlined requirements; 3) a description of general and specific facilities and equipment available, including the software used analyze study data; 4) an outline of previous research projects that are similar to the project requirements in which the organization and proposed personnel have participated; and 5) 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. Interested organizations are required to identify their size standards in accordance with the Small Business Administration. 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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