SOLICITATION NOTICE
A -- Recipient Epidemiology and Donor Evaluation Study III (REDS-III) – Central Laboratory
- Notice Date
- 6/16/2016
- 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
- HHS-NIH-NHLBI-16-27
- Point of Contact
- Kelli Malkin, , Allison M Cristman, Phone: 301-435-0359
- 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
- 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) 05-88-1, June 15, 2016. 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. Additionally, the Central Laboratory is required to execute protocols to evaluate the impact of Zika virus acquisition through blood transfusion 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. 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. Establish and actively participate in a REDS-III ZIKV Oversight Committee (and subcommittees as appropriate) with appropriate expertise that will regularly meet by phone calls or in-person and actively collaborate and participate in the review of the final Protocol (before it is approved by the NHLBI COR and CO). The REDS-III ZIKV Oversight Committee will monitor the study progress and address any issues encountered during protocol conduct, in concert with the REDS-III Executive Committee. The REDS-III ZIKV Oversight Committee will also actively collaborate and participate in the review of analyses, presentations, and publications for the Protocol in concert with the REDS-III Executive Committee and REDS-III Publication Committee. 2. Develop, implement, and update as appropriate, the manual of procedures (MOP) corresponding to the Protocol. 3. Obtain all necessary clearances necessary to conduct the Protocol with attention to NIH policy regarding the use of vertebrate animals. 4. Perform all laboratory testing in accordance with the Protocol. 5. 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. 6. Collect, process, ship, and store blood biospecimens per the Protocol. Use a biospecimen tracking system and maintain access to an inventory of biospecimens collected by the Protocol as well as their collection dates, processing characteristics, laboratory results and any other pertinent information that can be useful to characterize the biospecimens. The Central Laboratory is responsible directly or through subcontract(s) for all aspects related to the labeling of biospecimens, tubes, and/or aliquots collected for the Protocol and for ensuring the ability to link biospecimens and their data to other Protocol data for each animal. The Central Laboratory shall be responsible for establishing material transfer agreements, as appropriate, and for tracking shipment of biospecimens to other testing and/or storage facilities. The Central Laboratory shall obtain and compile all laboratory data obtained on biospecimens in dataset(s) for subsequent interpretation and statistical analysis. 7. Store biospecimens and associated data according to the study Protocol during REDS-III until no longer needed. 8. 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. 9. 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. 10. Interact with the Contracting Officer's Representative (COR) on programmatic research activity issues. 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 R&D Sources Sought notice published in the FedBizOpps on March 3, 2016, under solicitation number HHS-NIH-NHLBI-RDSS-HB-16-24. 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 five 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 Kelli Malkin at kelli.malkin@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: Kelli Malkin. Fax responses will not be accepted.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/HHS-NIH-NHLBI-16-27/listing.html)
- Record
- SN04152025-W 20160618/160616234553-4b5ea2ecb45fbe97f5ec95a7ec1518ce (fbodaily.com)
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