SOURCES SOUGHT
A -- Recipient Epidemiology and Donor Evaluation Study-IV-Pediatric (REDS-IV-P) – Center for Transfusion Laboratory Studies (CTLS)
- Notice Date
- 8/7/2017
- 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-SBSS-19HB00002R
- Archive Date
- 3/1/2019
- 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 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 NAICS code 541712 should not submit a response to this notice. The Division of Blood Diseases and Resources of the National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), is seeking small businesses with the ability to perform as the Center for Transfusion Laboratory Studies (CTLS) for the program entitled "Recipient Epidemiology and Donor Evaluation Study-IV-Pediatric (REDS-IV-P)." It is anticipated that one award will be made around March 2019 for a period of seven years. 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 epidemiological data on donors, donations, components, and transfused recipients as well as through the conduct of stand-alone multi-site clinical 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 Center for Transfusion Laboratory Studies (CTLS), one Data Coordinating Center (DCC), up to four domestic hubs, and one international collaborative program in Brazil. THIS NOTICE ADDRESSES THE CENTER FOR TRANSFUSION LABORATORY STUDIES ONLY. The REDS-IV-P Program is a 7-year program consisting of three phases: Phase 1 (Years 1-2): Development of study/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 donor, donation, component and patient databases; development of the resource sharing plan; conduct of Phase 1 database projects; and conduct of fast track 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 Phase 2 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): Conduct of study/project protocols; 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. The Center for Transfusion Laboratory Studies (CTLS) shall be responsible for the necessary testing conducted in the US, and for serving as the REDS-IV-P biospecimen repository. Additionally, the CTLS will function as a scientific center with substantive scientific involvement in the development and conduct of REDS-IV-P clinical study protocols and/or database projects that address key transfusion medicine scientific priorities; in particular, those with laboratory elements. More specifically, the CTLS shall be responsible for: 1) providing technical laboratory expertise and serving as an active participant in developing and prioritizing all REDS-IV-P research activities; 2) proposing, developing, and conducting the laboratory components of REDS-IV-P research studies; 3) leading the development and conduct of research studies that evaluate an emerging infectious threat to the blood supply, as directed by the NHLBI Contracting Officer and Contracting Officer's Representative(s); 4) performing infectious disease, genetic, molecular, immunological, hematological or other processing and testing of biospecimens according to protocol; 5) arranging and managing subcontracts with other laboratory testing facilities, as appropriate; and 6) serving as the REDS-IV-P biospecimen repository. Project Requirements NHLBI is seeking a Center for Transfusion Laboratory Studies (CTLS) with experience in transfusion medicine and blood banking laboratory methodologies, biorepository science, epidemiology and infectious diseases. In addition, expertise in at least 2 of the following fields is expected: immunology, molecular biology, "omics" such as genomics or metabolomics, hematology, or biochemistry. The CTLS shall have experience participating in large (> 5,000 study participants) multi-center, long term collaborative epidemiological research studies that include laboratory research components; have experience interacting and collaborating with multiple blood centers and transfusion services, with industry, as well as with other governmental agencies involved in addressing the safety and availability of blood products in the US. The CTLS shall also have experience handling a large number (>15,000 per year) of blood specimens from blood donors and/or transfused patient populations, including the accession, processing, testing, storage, and shipment of blood samples. The CTLS is expected to fulfill the following: 1. Manage the REDS-IV-P Center of Transfusion Laboratory Studies (CTLS) scope of work and ensure transmission of complete and accurate scientific data from the testing laboratory(ies) to the REDS-IV-P DCC, and shipment, storage, and testing of biospecimens in accordance with the REDS-IV-P Operating Procedures, protocols, and Manuals of Operations. 2. Actively participate in the REDS-IV-P Domestic and Brazil Steering Committees. 3. Help develop the domestic stand-alone study research portfolio and study protocols with attention to laboratory component(s). 4. Help develop the Brazil program's study protocols, with attention to the laboratory components. 5. As a member of the REDS-IV-P Domestic Steering Committee, develop and conduct database projects in collaboration with the domestic hubs and the DCC. 6. Lead the REDS-IV-P program's rapid response capability, as directed by the COR. 7. Collaborate with existing research networks, as directed by the COR. 8. Develop, train, and implement collection and management procedures for biospecimens and study laboratory data resulting from laboratory testing performed in the U.S., as appropriate. 9. Coordinate with the DCC to provide containers to participating REDS-IV-P study sites for shipment of biospecimens to the CTLS. 10. Conduct laboratory testing for the REDS-IV-P program. 11. Provide laboratory test result data to the DCC. 12. Store biospecimens from REDS-IV-P sites according to study protocols. 13. Help the DCC develop a Resource Dissemination Plan. 14. Serve as a resource and collaborate with non-REDS-IV-P funded investigators as directed by the COR. 15. Participate in all committee and subcommittee meetings, conference calls, and organizational training sessions of which the Principal Investigator and laboratory staff are members. 16. Participate in the development of data analyses and disseminate research results by preparing scientific reports for publication and presentation. 17. Interact with the NHLBI COR and Program Manager on programmatic research activity issues. Capability Statement Small business concerns 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 of the firm's status as a small business under NAICS code 541712 with a size standard of 500 employees; 2) qualifications and availability of personnel with training and/or experience in transfusion medicine and/or blood banking; 3) experience in laboratory research in the areas of blood banking and/or transfusion medicine; 4) experience participating in multiple large (> 5,000 study participants) multi-center, long term collaborative epidemiological research studies that include laboratory research components; and 5) experience interacting with multiple blood centers and transfusion services and in handling a large number (>15,000 per year) of blood specimens from blood centers and/or transfusion services, including the accession, processing, testing, storage, and shipment of blood samples. The capability statement must not exceed 15 pages in length and using a 12-point font size minimum. Interested small business 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. 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 HHSN26819HB00002R. The due date for receipt of statements is 3:00 p.m. Eastern Time on August 22, 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 OA. 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.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/HHS-NIH-NHLBI-SBSS-19HB00002R/listing.html)
- Record
- SN04616492-W 20170809/170807232145-0481f825f69a6f4f745e1e08bb807447 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |