MODIFICATION
A -- Recipient Epidemiology and Donor Evaluation Study III (REDS-III) – Domestic Hubs
- Notice Date
- 1/9/2015
- Notice Type
- Modification/Amendment
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD, Office of Acquisitions, 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, Maryland, 20892-7902
- ZIP Code
- 20892-7902
- Solicitation Number
- HHS-NIH-NHLBI-SBSS-HB-15-10
- Point of Contact
- Allison M Cristman, Phone: 301-435-0359, Cheryl A Jennings, Phone: (301) 435-0347
- E-Mail Address
-
allison.cristman@nih.gov, cj19f@nih.gov
(allison.cristman@nih.gov, cj19f@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- NOTE: Amendment changes are underlined in the text below. This is a 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 four (4) Domestic Hubs 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 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. MANDATORY QUALIFICATION CRITERIA Listed below are mandatory qualification criteria. The qualification criteria establish conditions that must be met at the time of receipt of capability statements by the Contracting Officer in order for your capability statement to be responsive. a.The 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 During the period from September 15, 2017 - March 14, 2020, 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 approvals 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. OTHER IMPORTANT CONSIDERATIONS The Government intends to negotiate four (4) cost reimbursement task orders 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 mandatory evaluation criterion and 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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