SOLICITATION NOTICE
A -- Recipient Epidemiology and Donor Evaluation Study III (REDS-III) – Domestic Hubs
- Notice Date
- 2/2/2015
- 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
- NHLBI-ECB-HB-15-10-AC
- 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
- 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) Domestic Hubs: 1) BloodCenter of Wisconsin (Contract No. HHSN268201100003I) 2) Institute for Transfusion Medicine (Contract No. HHSN268201100004I) 3) The Regents of the University of California (Contract No. HHSN268201100005I) 4) Yale University (Contract HHSN268201100006I) REGULATORY AUTHORITY The resultant contract modifications will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 05-80, January 29, 2015. 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 Domestic Hubs 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. The NHLBI anticipates that the four Domestic Hubs 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. PURPOSE, CONTRACT STRUCTURE, AND PERIOD OF PERFORMANCE The proposed action is a modification to each of four existing single award Indefinite Delivery, Indefinite Quantity (IDIQ) contracts, each with cost-reimbursement task orders. The contract modifications will extend the period of performance of each contract by two years, through March 14, 2020. 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. 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. PROJECT REQUIREMENTS The parent contracts will be extended in order to accommodate the anticipated task order for Phase 3, which will be performed during the period September 15, 2017 - March 14, 2020. In Phase 3, each of the four Domestic Hubs is expected to provide the necessary technical expertise and facilities to effectively perform the tasks and meet the requirements identified below: 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. 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 conducted as prescribed in FAR Part 10-Market Research, specifically the review and evaluation of responses to the Small Business Sources Sought notice and R&D Sources Sought notice published in the FedBizOpps on December 30, 2014, with the same solicitation number and title. The incumbent contractors listed under the Background section above were each awarded a contract based on full and open competition under Solicitation No. NHLBI-HB-11-03. 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 Domestic Hubs for over three 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 Allison Cristman at allison.cristman@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: Allison Cristman. Fax responses will not be accepted.
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