SOLICITATION NOTICE
A -- Recipient Epidemiology and Donor Evaluation Study III (REDS-III) – Central Laboratory
- Notice Date
- 2/2/2015
- 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
- NHLBI-ECB-HB-15-08-AC
- 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
- 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. dba Blood Systems Research Institute for the Recipient Epidemiology and Donor Evaluation Study III (REDS-III) Central Laboratory. REGULATORY AUTHORITY The resultant contract modification will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 05-80, January 29, 2015. This acquisition is conducted under the procedures as prescribed in FAR subpart 15-Contracting by Negotiation at an amount exceeding the simplified acquisition threshold ($150,000). STATUTORY AUTHORITY This acquisition is conducted under the authority of 41 U.S.C. 253(c) under provisions of the statutory authority of FAR Subpart 6.302-1 - Only one responsible source and no other supplies or services will satisfy agency requirements 41 U.S.C. 253(c)(1). 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. 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 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. 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. Additionally, the modification will extend the period of performance of the contact by two years, through March 14, 2020. PROJECT REQUIREMENTS The parent contract will be extended in order to accommodate the anticipated task order for Phase 3, which will be performed during the period September 15, 2017 - March 14, 2020. In Phase 3, the CL 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 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. 2. 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. 3. The Central Laboratory shall contribute in presenting study data in the form of presentations at scientific meetings and publications in peer-reviewed scientific journals. 4. 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. 5. 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. In Phase 3, the Central Laboratory shall finalize the conduct of those REDS-III research protocols with a laboratory component that were approved in Phases 1 and 2. 6. 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. 7. 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. 8. Participate in all committee and subcommittee meetings, conference calls, and organizational training sessions of which the Principal Investigator and laboratory staff are members. CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATION The determination by the Government to award a contract modification without providing for full and open competition is based upon the market research conducted as prescribed in FAR Part 10-Market Research, specifically the review and evaluation of the responses to the Small Business Sources Sought notice and R&D Sources Sought notice published in the FedBizOpps on December 30, 2014, with the same solicitation number and title. The incumbent contractor, Blood Systems, Inc. dba Blood Systems Research Institute (BSRI), was awarded a contract based on full and open competition under Solicitation No. NHLBI-HB-11-01. Full source selection procedures were followed during pre-award activities, including conduct of a peer review and a secondary review of the proposal submitted, discussions with the offeror regarding the technical and cost proposals, and past performance evaluation. The contract was awarded in March 2011. BSRI has been performing as the REDS-III Central Lab for over three years under Task Orders 1 and 2. The Central Lab is a critical part of the REDS-III program, and its performance impacts the functionality of the four Domestic hubs and the three International sites, and the analysis and study management performed by the Data Coordinating Center. 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 Allison Cristman at allison.cristman@nih.gov, or by U.S. mail to the National Heart, Lung, and Blood Institute, Office of Acquisitions, Extramural Contracts Branch, 6701 Rockledge Drive, Suite 6100, Bethesda, MD 20892-7902, Attention: Allison Cristman. Fax responses will not be accepted.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/NHLBI-ECB-HB-15-08-AC/listing.html)
- Record
- SN03631042-W 20150204/150202235130-a119e0505db51444b2ec501fbf412dc7 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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