SOURCES SOUGHT
A -- Recipient Epidemiology and Donor Evaluation Study-IV-Pediatric (REDS-IV-P) – Domestic Hub
- Notice Date
- 8/15/2017
- 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-RDSS-19HB00003R
- Point of Contact
- Kelli Malkin, , John Turner, Phone: 3014029787
- E-Mail Address
-
Kelli.Malkin@nih.gov, john.turner@nih.gov
(Kelli.Malkin@nih.gov, john.turner@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Introduction This is a Research and Development (R & D) Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources to perform a potential R & D requirement. Your responses to the information requested will assist the Government in determining the appropriate acquisition method. The North American Industry Classification System (NAICS) code for the proposed acquisition is 541712. The Division of Blood Diseases and Resources of the National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), is seeking qualified sources with the ability to perform as Domestic Hub for the program entitled "Recipient Epidemiology and Donor Evaluation Study-IV-Pediatric (REDS-IV-P)." It is anticipated that up to four awards will be made around March 2019 for a period of seven years as research contracts. Background The goal of the Recipient Epidemiology and Donor Evaluation Study-IV-Pediatric (REDS-IV-P) program is to evaluate and improve the safety and availability of the blood supply as well as the safety and effectiveness of transfusion therapies with attention to not only adults, but also neonates and children who need transfusion. This will be accomplished by the establishment of a seven-year multicenter program in the US and in Brazil, charged with conducting epidemiologic and laboratory studies in blood donors and transfusion recipients. This cohesive and comprehensive multicenter program will use a multi-targeted strategy to proactively address potential threats to the nation's blood supply; evaluate how to enhance the effectiveness and safety of transfusions; and serve as a resource for ongoing work in transfusion research. The REDS-IV-P program infrastructure will allow for evaluation of key research questions in transfusion medicine that are best studied through the analysis of a comprehensive set of demographic, laboratory and clinical data on donors, donations, components, and transfused recipients compiled in core databases as well as through the conduct of stand-alone multi-site laboratory and observational studies. Similar to its predecessor programs, REDS-IV-P will include a rapid research response capability to address emerging threats to the blood supply. The program will be poised to evaluate a new infectious agent quickly for its prevalence and incidence among blood donors, transfusion-transmission potential, risk factors, and clinical relevance to the blood recipient population and provide these data to inform the implementation of enhanced blood safety measures and policies. NHLBI plans to support one Data Coordinating Center (DCC), one Center for Transfusion Laboratory Studies (CTLS), up to four domestic hubs, and one international collaborative program in Brazil. THIS NOTICE ADDRESSES THE DOMESTIC HUBS ONLY. The REDS-IV-P Program is a 7-year program consisting of three phases: Phase 1 (Years 1-2): Development of multi-site research study and database project protocols, design of forms, REDS-IV-P Operating Procedures, Manuals of Operations for each study protocol and databases; review of data collection and research studies by oversight and regulatory boards; development and pilot of the linkable donor, donation, component and patient/recipient databases; development of the resource sharing plan; conduct of phase 1 database projects; and conduct of research studies that can be developed and completed within phase 1. Phase 2 (Years 3-5): Development of new study/project protocols, design of forms, and Manuals of Operations for study protocols; review of data collection and research projects by oversight and regulatory boards; conduct of study and database project protocols; cumulative compilation of all databases and datasets; laboratory testing; analysis of data; and dissemination of findings through presentations and publications. Phase 3 (Years 6-7): Development and conduct of new study/project protocols, as appropriate; finishing transmission of all study data to the DCC; analysis of data; dissemination of findings through presentations and publications; closure of databases; and provision of all deliverables to NHLBI. Project Requirements NHLBI is seeking Domestic Hubs to collaboratively conduct epidemiologic research that address blood banking and transfusion research priorities. Each hub shall consist of a blood center (defined as one -- or a system of -- blood collection centers) and one or more transfusion service(s) that serve(s) a mixed hospital base including tertiary care and community hospitals. All REDS-IV-P data will be provided by each hub to the DCC for compilation in multicenter datasets/databases. Participating hospitals shall provide access to data on not only large volumes of adult patients admitted to services where transfusion is common (intensive care units, cardiac surgery, orthopedic surgery, oncology/cancer center, and trauma service), but also access to obstetrical, neonatal intensive care, and pediatric patients (both in and out-patient services). Research-quality sharable and linkable multi-center donor/donation, component, and patient (including transfusion recipient) databases shall be established based on the model established in the REDS-III program (https://reds-iii.rti.org). For the patient/recipient database, electronic medical record (EMR) information shall be captured at each participating hospital on not only transfused patients but also on non-transfused patients to provide comparative data. The "linkable" database capability refers to the ability to link demographic, clinical, and laboratory data on blood donors, their donations, their blood components, and the transfused recipients who received their blood components. The aim will be to include in this linked database comprehensive data on at least 85% of donations whose products have been transfused to patients at participating hospitals. Each Domestic Hub is expected to fulfill the following requirements: 1. Manage the REDS-IV-P Domestic program scope of work and ensure transmission of complete and accurate scientific data from the domestic hub to the REDS-IV-P DCC, in accordance with the REDS-IV-P Operating Procedures, protocols, and Manuals of Operations. All scientific data transmitted to the DCC shall be considered a deliverable for this contract. 2. Actively participate in the REDS-IV-P Domestic Steering Committee. 3. As a member of the REDS-IV-P Domestic Steering Committee, develop the stand-alone study research portfolio and corresponding study protocols. These stand-alone epidemiological studies need to address research priorities in blood banking and/or transfusion medicine. 4. As a member of the REDS-IV-P Domestic Steering Committee, develop analysis requests for data compiled in large multi-center datasets/databases (referred to as database projects) in collaboration with the DCC. These database projects need to address research priorities in blood banking and/or transfusion medicine and should query REDS-IV-P or existing and accessible large quality multicenter dataset(s)/database(s). 5. Ensure access to demographically diverse adult and neonatal/pediatric patient populations and to services that perform most of the blood transfusions. It will be desirable that at least a total of 20,000 RBC transfusion exposures occur per year at the hub's participating hospitals/outpatient clinics. It will also be desirable that the consortium of hospitals participating in the hub admit the following minimum number of patients each year at the following hospital services: I. Adult intensive care units, minimum of 1,000 cross-matched adult patients per year; II. Adult cardiac surgery, minimum of 1,000 cross-matched adult patients per year; III. Adult orthopedic surgery, minimum of 500 cross-matched adult patients admitted per year; IV. Adult oncology/cancer center, minimum of 1,000 cross-matched adult patients per year; V. Adult trauma service, minimum of 1,000 cross-matched adult patients per year, or alternatively, participation in a level 1 trauma program; VI. Obstetrical service, minimum of 2,000 deliveries per year; VII. Neonatology intensive care unit(s), minimum of 1,000 neonates admitted to an intensive care per year; VIII. Pediatric intensive care unit(s), minimum of 1,000 children admitted to an intensive care per year; IX. Oncology/cancer center, minimum of 100 pediatric patients with a new cancer diagnosis admitted per year; X. Pediatric trauma service, minimum of 200 pediatric trauma patients admitted per year, or alternatively, participation in a level 1 pediatric trauma program. Additionally, access to data on chronically transfused pediatric patients will be desirable. 6. The hub's blood center must collect a minimum of 75,000 allogeneic blood donations per year and be the major supplier of blood to the participating hospitals within the hub. 7. Establish a Centralized Data Collection Center (CCC). 8. Serve as a resource and collaborate with non-REDS-IV-P funded investigators as directed by the Contracting Officer Representative (COR). Serving as a resource can take many forms, including providing access to scientific experts participating in the REDS-IV-P domestic program; reviewing and supporting requests from interested non-REDS-IV-P investigators for descriptive epidemiological analyses of the REDS-IV-P datasets/databases to inform their study design; providing REDS-IV-P biospecimens; and whenever possible, participating in collaborative studies led by non-REDS-IV-P investigators (funded by R01s or other funding mechanisms). 9. Help the DCC develop a Resource Dissemination Plan to actively promote REDS-IV-P data and biospecimen resources to the scientific community. 10. Collaborate as directed by the COR with existing research networks. 11. 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. 12. Obtain all necessary governmental, administrative and regulatory approvals to ensure data and biospecimen sharing capabilities and participation in and successful completion of all studies and projects included in the REDS-IV-P Domestic research portfolio. 13. Help conduct database projects in collaboration with the REDS-IV-P DCC. 14. Participate in, coordinate, and successfully conduct the REDS-IV-P stand-alone study protocols that have been approved by the REDS-IV-P Domestic Steering Committee. 15. Collect, process, store, and ship biospecimens, as required by stand-alone study protocols. 16. Participate in the development of REDS-IV-P data analyses and disseminate research results by preparing scientific reports for publication and presentation. 17. Mentor a minimum of one junior investigator in the areas of blood banking and/or transfusion medicine research starting at the latest in year 2 of the program, and prepare the investigator to apply for grants. 18. Interact with the NHLBI COR and the NHLBI Program Manager on programmatic research activity issues. Capability Statement Qualified sources that believe they possess the capabilities necessary to undertake this work should submit complete documentation of their capabilities to the Contracting Officer. Capability statements must provide evidence of ability to perform and demonstrated experience in performing the tasks described above. Capability statements will be reviewed based on the following: 1) Evidence that the hub consists of a blood center (blood center, blood bank, or academic institution) and one or more transfusion service(s) which support(s) a mixed hospital base of tertiary care and community hospitals within the United States (U.S.); 2) Demonstrated expertise in transfusion medicine and/or blood banking and in the operation of a hospital transfusion medicine service and/or blood center; and 3) Accessible evidence of ability to fulfill the functions described in tasks 1 through 18 above. 4) If a small business concern, organizations are required to identify themselves as such and their size standard in accordance with the Small Business Administration. The capability statement must not exceed 9 pages in length and use a 11-point font size minimum. 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. Point of Contact: Kelli Malkin, Contracting Officer, Phone: (301) 827-7723, Email: Kelli.Malkin@nih.gov. John Turner, Contract Specialist, Phone: (301) 827-7735, Email: John.Turner@nih.gov. 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 RKL2/6114 MSC 7902, Bethesda, MD, 20892-7902, UNITED STATES Submission Instructions: Interested parties shall submit capability statements via the FedConnect web portal (www.fedconnect.net) and reference the FedConnect Sources Sought Number HHSN26819HB00003R. The due date for receipt of statements is 3:00 p.m. Eastern Time on August 29, 2017. Vendors can register with FedConnect at https://www.fedconnect.net/FedConnect/default.htm. Please note that FedConnect is used by multiple federal agencies and therefore FedConnect assistance will be provided by Compusearch Software Systems, not the NHLBI Office of Acquisitions. More information about registration requirements can be found by downloading the FedConnect Ready, Set, Go! Guide at https://www.fedconnect.net/fedconnect/Marketing/Documents/FedConnect_Ready_Set_Go.pdf. For assistance in registering or for other FedConnect technical questions please call the FedConnect Help Desk at (800) 899-6665 or email at support@fedconnect.net. Please use the Contracting Officer/ Contract Specialist contact information provided, should you require a waiver not to use FedConnect for submitting. All responses must be received by the specified due date and time in order to be considered. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in the response. No proprietary, classified, confidential, or sensitive information should be included in your 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 review of the responses received, pre-solicitation and solicitation notices may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation.
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