SOLICITATION NOTICE
A -- Recipient Epidemiology and Donor Evaluation Study III (REDS-III) – Data Coordinating Center
- Notice Date
- 6/28/2017
- 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
- HHSN268201100002I-NOI
- Archive Date
- 7/28/2017
- Point of Contact
- Kelli Malkin,
- E-Mail Address
-
Kelli.Malkin@nih.gov
(Kelli.Malkin@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 Research Triangle Institute for the Recipient Epidemiology and Donor Evaluation Study III (REDS-III) Data Coordinating Center (DCC). THIS IS A SYNOPSIS. THIS IS NOT A SOLICITATION. BACKGROUND The incumbent Contract No. HHSN268201100002I is for the Data Coordinating Center 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. PURPOSE, CONTRACT STRUCTURE, AND PERIOD OF PERFORMANCE The proposed action is a modification to an existing single award Indefinite Delivery, Indefinite Quantity (IDIQ) contract, with cost-reimbursement task orders. The contract modification will increase the maximum ordering value of the IDIQ contract. This modification will not obligate any funds; funds are obligated under task orders that are issued against the base IDIQ contract. 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. This modification is necessary to award Phase 3 of the contract. PROJECT REQUIREMENTS In Phase 3, the 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 Executive Committee, Domestic and International Steering Committees, and International Advisory Committee 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 (or designee) shall attend the Executive, Steering, and International Advisory Committee calls. The Principal Investigator for the data coordinating center (or designee) shall attend the combined Domestic Steering Committee and International Advisory Committee meetings that are held in the U.S.; and shall be a voting member for each of the Steering 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 and/or action items as directed 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 REDS-III participants when minutes and materials are posted. The Contractor shall provide funding and logistical support for the Executive Committee External Chair (also the chair of the REDS-III Domestic Steering Committee). 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 earlier phases of the REDS-III contract in collaboration with the REDS-III Executive 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 Executive Committee 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, Executive and 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 Executive Committee 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 and maintain all necessary data management and tracking systems. The Contractor shall develop, implement, and maintain 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 and maintain 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. In consultation with the central laboratory, the Contractor will be responsible for all aspects related to the labeling of biospecimens, tubes, and/or aliquots collected in REDS-III, including determining which sites need labels; how many labels are needed per site; the label design, configuration, and content, thus ensuring their ability to be linked to other study data on the subject; their purchase; and their delivery to the appropriate site, whether domestic or international, at the appropriate time. The Contractor shall track shipment of biospecimens from centers to the REDS-III central laboratory or to other testing and/or storage facilitites. 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 and provide REDS-III analytical datasets as directed by the Contracting Officer's Representative(s). 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. REDS-III data shall be analyzed centrally by the REDS-III DCC, unless otherwise specified by the NHLBI COR. As directed by the COR, the contractor shall help REDS-III domestic, international, and central laboratory investigators develop new data analysis requests that use REDS-III data. As directed by the COR, analyses of data may be conducted by one of the REDS-III domestic or international site, or by the central laboratory. The contractor shall provide analytical datasets with appropriate documentation to REDS-III participants as directed by the COR(s); and develop data use agreements, as appropriate. All data analysis requests (whether the analysis is led by the DCC or by the domestic site, international site, or central laboratory) will be subject to review by the relevant REDS-III Steering Committee and the REDS-III Executive Committee, and shall be approved by the CO and COR before being implemented. All analyses results conducted by the domestic site, international site, or central laboratory contractor will be subject to review by the relevant REDS-III Steering Committee members, the REDS-III Executive Committee, and the REDS-III Publication Committee. Abstracts, presentations, press releases, reports or manuscript for publications resulting from any REDS-III data analyses (whether the analysis is led by the DCC or by the domestic site, international site, or central laboratory) shall adhere to the REDS-III publication policy. 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 in adherence with the REDS-III publication policy; 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 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 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), provide analytical datasets to REDS-III participants and NHLBI, and create and deliver public use data sets with documentation to NHLBI, as directed by the Contracting Officer's Representative(s). The contractor shall provide analytical datasets with appropriate documentation to REDS-III participants as directed by the Contracting Officer's Representative(s), and establish data use agreements, as appropriate. All REDS-III analytical datasets with appropriate documentation shall be delivered to NHLBI, by the end of Phase 3 (March 2019), or earlier as directed by the Contracting Officer's Representative(s). The Contractor shall transform the REDS-III study-specific datasets and domestic centralized donor, donation, component, patient databases 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 public use 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. Instructions on how to link data across datafiles/datasets/databases shall be provided to REDS-III participants and to NHLBI, as well as any necessary data files, as appropriate. 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. 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 parties 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.
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