SOURCES SOUGHT
A -- Recipient Epidemiology and Donor Evaluation Study III (REDS-III) – Central Laboratory
- Notice Date
- 3/3/2016
- 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-HB-16-24
- Point of Contact
- Kelli Malkin, , Allison M Cristman,
- E-Mail Address
-
Kelli.Malkin@nih.gov, allison.cristman@nih.gov
(Kelli.Malkin@nih.gov, allison.cristman@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Research and Development Sources Sought Notice Description 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. Background The National Heart, Lung, and Blood Institute (NHLBI) is seeking a Central Laboratory 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 Central Laboratory 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. Additionally, the Government anticipates that the Central Laboratory will be required to execute protocols to evaluate the impact of Zika virus acquisition through blood transfusion. Project Requirements During the period from now until March 14, 2020, the Central Laboratory (CL) is expected to provide the necessary technical expertise and facilities to effectively perform the tasks and meet the requirements identified below: 1. Propose, develop, and conduct laboratory studies in blood banking and transfusion medicine that will advance blood transfusion safety and availability. REDS-III study protocols with laboratory components, i.e. laboratory studies, shall be approved by the appropriate Steering Committee. When requested by the NHLBI Contracting Officer's Representative (COR), study protocols shall be reviewed by an NHLBI Observational Study Monitoring Board (OSMB) advisory to the NHLBI. The Central Laboratory shall obtain all necessary administrative and regulatory clearances necessary to conduct REDS-III activities. The Central Laboratory will provide technical advice to the REDS-III international collaborative programs to help each of them conduct their laboratory studies. 2. Develop and implement a scientific protocol on characterization of blood transfusion-transmission of Zika virus using animal models. For this protocol, the Central Laboratory will perform the following tasks: a. Obtain all necessary clearances to conduct the protocol, with attention to NIH policy regarding the use of vertebrate animals. b. Develop, implement, and update the Manual of Procedures (MOP) for the protocol. c. Provide all statistical and analytical support for the analysis of the data collected and managed for the protocol. d. Collect, organize, track, and store the protocol data using secure data collection, tracking, management, and storage procedures. Assure the quality of the Protocol data collected and stored. e. Conduct all data analyses and interpret the results obtained from these data analyses to address all aims of the Protocol. Check all data for accuracy f. Disseminate results from the protocol in the form of presentations at scientific meetings, abstracts, and publications in peer-reviewed scientific journals. Provide all resulting presentations and publications to the REDS-III Data Coordinating Center for compilation and posting on the REDS-III website. Any presentation or publication of REDS-III Protocol data will be in accordance with the REDS-III policy detailed in the REDS-III Publications Committee Policy Manual and amendment(s) thereof. 3. The Principal Investigator of the Central Laboratory shall serve as a voting member of the REDS-III International Advisory Committee. As a member of the International Advisory Committee, actively participate in the review and approval of the REDS-III International study portfolio and evaluate program progress to ensure that the overall objectives of the REDS-III program are being met. 4. The Principal Investigator of the Central Laboratory shall serve as a voting member of the REDS-III Domestic Steering Committee and each International Steering Committee. As a member of the Domestic Steering Committee and each International Steering Committee (and their subcommittees, as appropriate), provide technical laboratory expertise and serve as an active participant in developing and prioritizing REDS-III domestic and international research activities, in overseeing and ensuring the progress of ongoing studies, and in developing, reviewing and approving analyses, presentations, and publications. 5. As a member of the REDS-III Domestic and International Steering Committees, develop and finalize REDS-III study protocols. As a member of the REDS-III Domestic and International Steering Committees, provide technical laboratory expertise and participate in the development of REDS-III study protocols and in the development and finalization of associated Manuals of Procedures by providing technical expertise in the areas of blood banking and transfusion and laboratory medicine for studies to be performed in the REDS-III program. Guidance shall be provided for the collection of blood samples and other biospecimens and their processing, temporary storage, and delivery to the REDS-III Central Laboratory or other testing facility. The final domestic and international protocols must be approved by the REDS-III Domestic and International Steering Committees, respectively and by the Oversight Committee before being approved in writing by the NHLBI Contracting Officer. 6. The Central Laboratory shall participate in the development of REDS-III analysis requests and analytical plans, as appropriate, and help with the interpretation of the results obtained by data analysis. The Central Laboratory shall contribute in presenting study data in the form of presentations at scientific meetings and publications in peer-reviewed scientific journals. Any data analysis request(s) and presentation or publication of REDS-III data will be in accordance with the REDS-III policy detailed in the REDS-III Publications Committee Policy Manual and amendment(s) thereof. 7. The Central Laboratory shall coordinate with the Data Coordinating Center (DCC) to provide containers to the REDS-III domestic hubs and international sites for shipment of biospecimens to the CL. For the Domestic hubs, the CL shall bear the cost for shipping biospecimens from the hubs to the CL or other testing sites, and for shipping residual volume back to the CL for storage, as appropriate per protocol specifications. For international sites, the CL shall bear the cost for shipping biospecimens from the sites to the CL or other testing sites in the U.S., and for shipping residual volume back to the CL for storage, as appropriate per protocol specifications. The international sites shall be responsible for the costs associated with shipping biospecimens to in-country testing facilities and for the costs of storage of biospecimens that are not shipped to the U.S. 8. In accordance with REDS-III study protocols, the Central Laboratory shall perform infectious disease, molecular, genetic, immunological, and hematological tests such as antigen, antibody, and nucleic acid assays for infectious agents, testing for human leukocyte antigens (HLA), testing for products with immunomodulatory, pro-apoptotic and pro-inflammatory properties such as cytokines and chemokines, characterization of leukocyte populations with immunoregulatory properties, etc. It is expected that most testing in the U.S. shall be performed by the CL. For those assays that are better conducted by other testing facilities, the CL shall be responsible for arranging and managing the necessary subcontracts with each U.S. testing facility. 9. Develop and implement collection and management procedures for laboratory data resulting from laboratory testing performed in the U.S. 10. Transmit laboratory test results electronically to the DCC in an acceptable format within the timeframe specified in the study-specific Manual of Operations. Results from any quality control assessments specified in protocols shall be transmitted to the DCC. 11. Store biospecimens from participating hubs according to study protocols. Biospecimens shall be stored at the CL until no longer needed. If the biospecimens and associated genotypic and/or phenotypic data may be of value for further study by the scientific community, the REDS-III Domestic and International Steering Committees can consider submitting applications to the NHLBI for consideration to transfer biospecimen collections to the NHLBI Biologic Specimen Repository for long-term storage and access by the scientific community. Shipping costs from the CL to the NHLBI Biologic Specimen Repository shall be borne by the NHLBI Biorepository. 12. Participate in all committee and subcommittee meetings, conference calls, and organizational training sessions of which the Principal Investigator and laboratory staff are members. 13. Interact with the Contracting Officer's Representative (COR) on programmatic research activity issues. Other Important Considerations The Government intends to negotiate a cost reimbursement task order for the period of September 15, 2016 - March 14, 2020. Capability Statement - How to Submit a Response Organizations 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 project requirement separately. Additionally, the capability statement should 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; and 4) 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. 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 notice number. All capability statements sent in response to this Sources Sought Notice must be submitted electronically (via email) to Kelli Malkin, Contracting Officer at kelli.malkin@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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