SOLICITATION NOTICE
A -- Recipient Epidemiology and Donor Evaluation Study III (REDS-III) – Central Laboratory
- Notice Date
- 7/10/2017
- 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
- HHSN268201100001I-NOI
- Archive Date
- 8/8/2017
- Point of Contact
- Kelli Malkin,
- E-Mail Address
-
Kelli.Malkin@nih.gov
(Kelli.Malkin@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 Blood Systems, Inc. for the Recipient Epidemiology and Donor Evaluation Study III (REDS-III) - Central Laboratory. THIS IS A SYNOPSIS. THIS IS NOT A SOLICITATION. BACKGROUND The incumbent Contract No. HHSN268201100001I is for the Central Laboratory 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. PURPOSE, CONTRACT STRUCTURE, AND PERIOD OF PERFORMANCE The proposed action is a modification to an existing single award Indefinite Delivery, Indefinite Quantity (IDIQ) contract, with cost-reimbursement task orders. The contract modification will increase the maximum ordering value of the IDIQ contract. This modification will not obligate any funds; funds are obligated under task orders that are issued against the base IDIQ contract. 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. This modification is necessary to award Phase 3 of the contract. PROJECT REQUIREMENTS In Phase 3, the Central Laboratory is expected to provide the necessary technical expertise and facilities to effectively perform the tasks and meet the requirements identified below: 1. The Principal Investigator of the central laboratory shall serve as voting member of the REDS-III Domestic Steering Committee and International Steering and Advisory Committees. As a member of the Domestic Steering Committee and International Steering Committees (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. 2. If necessary in Phase 3, the central laboratory shall coordinate with the DCC to provide containers to the REDS-III domestic hubs and international sites for shipment of biospecimens to the central laboratory. For the Domestic program, the central laboratory shall bear the cost for shipping biospecimens from the hubs to the central laboratory or other testing sites; and for shipping residual volume back to the central laboratory for storage, as appropriate per protocol specifications. For international sites, the central laboratory shall bear the cost for shipping biospecimens from the sites to the central laboratory or other testing sites in the U.S.; and for shipping residual volume back to the central laboratory 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. 3. 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 central laboratory. For those assays that are better conducted by other testing facilities, the central laboratory shall be responsible for arranging and managing the necessary subcontracts with each U.S. testing facility. 4. In accordance with REDS-III study protocols, 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. 5. Store and manage biospecimens according to study protocols, and distribute biospecimens to REDS-III and non-REDS-III investigators, as approved by NHLBI. Biospecimens shall be stored at the central laboratory per protocol. 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. If the application is approved and biospecimens are transferred for long term storage in the NHLBI Biologic Specimen Repository, shipping costs from the central laboratory (or other REDS-III approved storage facility) to the NHLBI Biologic Specimen Repository shall be borne by the REDS-III central laboratory. The central laboratory shall be responsible for distributing biospecimens to REDS-III and non-REDS-III investigators as approved by NHLBI; and for the development of Material Transfer Agreements (MTAs) before biospecimen transfers occur. The MTAs shall be reviewed by the Contracting Officer and Contracting Officer Representative before their implementation by the central laboratory. 6. Develop new REDS-III Data Analysis request(s) in collaboration with the REDS-III DCC and as directed by the COR, and disseminate REDS-III research results by preparing scientific reports for publication and presentation. REDS-III data shall be analyzed centrally by the REDS-III DCC, unless otherwise specified by the NHLBI COR. As directed by the COR, develop data analysis requests in collaboration with the DCC that use REDS-III data. If approved by the COR, the contractor can directly conduct analyses of specific study data. In which case the contractor shall provide the necessary statistical and analytical capabilities as well as the necessary statistical programming expertise, as reviewed and approved by the NHLBI COR. All data analysis requests (whether the analysis is led by the DCC or by the contractor) will be subject to review by the respective REDS-III Steering Committee members and the REDS-III Executive Committee, and shall be approved by the CO and COR before being implemented. All analyses results conducted by the contractor will be subject to review by the appropriate REDS-III Steering Committee members, the REDS-III Executive Committee and the REDS-III Publication Committee. The contractor will disseminate REDS-III data results through publications and presentations. Abstracts, presentations, press releases, reports or manuscripts for publications resulting from any REDS-III data analyses (whether the analysis is led by the DCC or by the contractor) shall adhere to the REDS-III publication policy. 7. Participate in all committee and subcommittee meetings, conference calls, and organizational training sessions of which the Principal Investigator and laboratory staff are members. 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 Kelli Malkin at kelli.malkin@nih.gov.
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