SOLICITATION NOTICE
B -- Establish Cell/Tissue Lines--Georgetown University Tissue Culture Shared Resource
- Notice Date
- 8/22/2014
- 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-CSB-(HG)-2014-235-DLM
- Archive Date
- 9/12/2014
- Point of Contact
- Dorothy Maxwell, Phone: 301-435-0352
- E-Mail Address
-
maxwelld@mail.nih.gov
(maxwelld@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- INTRODUCTION: THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR A PROPOSAL. A SOLICITATION DOCUMENT WILL NOT BE ISSUED AND PROPOSALS WILL NOT BE REQUESTED. The National Institute of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI) Office of Acquisition (OA) on behalf of the National Human Genome Research Institute, (NHGRI), intends to negotiate and award a purchase order on a noncompetitive sole source basis to Georgetown University, 3970 Reservoir Road, NW, TRB W314, Washington, DC 20057 to provide: standard laboratory procedures that optimize and meet NIH/NHGRI requirements to establish cell/tissue lines, and/or high quality DNA/RNA extraction from blood/tissue samples, with capacity for long-term frozen storage. BACKGROUND: The National Institutes of Health (NIH) mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability. The National Human Genome Research Institute (NHGRI) mission has expanded to encompass a broad range of studies aimed at understanding the structure and function of the human genome and its role in health and disease. To that end NHGRI supports the development of resources and technology that will accelerate genome research and its application to human health. A critical part of the NHGRI mission continues to be the study of the ethical, legal and social implications (ELSI) of genome research. The National Institutes of Health (NIH) is the nation's foremost federally funded biomedical research institution. NIH is comprised of twenty-seven Institutes, Centers and Divisions. The Hatfield Clinical Research Center (CRC) located on the NIH campus includes clinical, laboratory and administrative staff who support the Institutes as they conduct clinical research working with inpatients and outpatients participating in research studies at the NIH. The NIH CRC serves the needs of the NIH Intramural Research Program by providing a safe and effective environment for the care and treatment of patients participating in structures biomedical research protocols. Under IRB-approved protocols, the NHGRI-DIR and other NIH institutes (IC's) study the care and treatment of patients with rare genetic disorders. Care is rendered to patients with genetic disease and the correct diagnosis of these genetic disorders impacts the prognosis, medical management, and individual and familial genetic risk. While a patient is participating on a research protocol, they may require specific genetic testing that is not currently available at the NIH Clinical Research Center (CRC) necessitating the patient's laboratory samples be sent to an outside facility to perform the requested service. NIH/NHGRI investigators also require access to high quality extracted DNA/RNA and established cell lines to pursue further research analysis. PURPOSE: The Contractor shall provide the expertise in standard laboratory procedures that optimize and meet NIH/NHGRI requirements to establish cell/tissue lines, with capacity for long-term frozen storage and/or high quality DNA/RNA extraction for patients studied under NHGRI or other NIH-IC protocols in collaboration with Georgetown University Tissue Culture Shared Resource (GU-TCSR) given their expertise and past laboratory genetic support services that remain integral to the research mission of NIH/NHGRI investigators. NIH/NHGRI requirements include application of standard laboratory procedures that optimize and meet NIH/NHGRI requirements to establish cell/tissue lines, with capacity for long-term frozen storage and/or high quality DNA/RNA extraction. NIH/NHGRI investigators also require timely access to inventory of NIH/NHGRI sample(s), which are available upon request for transport back to NIH. Contractor Requirements: 1. The Contractor shall provide standard laboratory procedures that optimize and meet NIH/NHGRI requirements to establish cell/tissue lines, and/or high quality DNA/RNA extraction from blood/tissue samples, with capacity for long-term frozen storage. 2. The Contractor shall provide Long-term frozen storage of DNA, RNA and cell/tissue lines (EBV-transformed lymphoblasts, fibroblasts). 3. The Contractor shall provide timely access to inventory of NIH/NHGRI sample(s), which are available upon request by for transport back to NIH. 4. The Contractor when/if requested, shall provide molecular cytogenetic and/or DNA-based testing for rare disorders in collaboration with NHGRI PIs. 5. The Contractor shall maintain legacy NHGRI stored samples that include frozen fibroblasts, DNA/RNA aliquots, EBV-transformed cell lines and fixed metaphase cell pellets collected over the years (1997-current) that are available as directed by the PI/researcher. The Georgetown University Tissue Culture Shared Resource (GU-TCSR) provides the expertise to EBV-transform lymphoblast cell lines and to maintain active lines for study, as well as provide the service of extracting DNA and/or RNA from blood/tissue samples from patients studied under NHGRI or other NIH-IC protocols. In addition Georgetown University maintain legacy NHGRI stored samples that include frozen fibroblasts, DNA/RNA aliquots, EBV-transformed cell lines and fixed metaphase cell pellets collected over the years (1997-current) that are available as directed by the PI/researcher. This is a recurring need for the Office of the Clinical Director, NHGRI-DIR and other ICs at NIH. A. Specific Tasks: 1. EBV transformed lymphoblast preparation, skin fibroblast culture, and DNA/RNA isolation. 2. Long-term frozen storage of DNA, RNA, and cell lines (EBV-transformed lymphoblasts, fibroblasts). 3. In select cases, FISH testing and/or molecular testing may be performed on blood samples/DNA by investigator request. 4. Timely access to inventory of NIH/NHGRI sample(s), which are available upon request for transport back to NIH. B. Desired Results/Functions/End Items: 1. EBV transformed lymphoblast preparation, skin fibroblast culture, DNA/RNA isolation will be performed and long-term sample storage provided in the laboratories of the Tissue Culture Shared Resource at Georgetown University in Washington, DC. 2. Duration: Capacity to receive, process, maintain and store samples (or the prepared sample derivatives/aliquots for at least 1 year but capable of extending this to 5 or more years, depending on NHGRI/NIH requirements. C. Technical Specifications/Standards/Methods: 1. Preparing and storing EBV-transformed lymphoblast pellets from blood samples obtained on patients enrolled on NHGRI/NIH protocols. Methodology used should apply standard laboratory procedures that optimize and meet NIH/NHGRI requirements to establish lymphoblastoid pellets for long-term storage under conditions to maintain them for future use. 2. Tissue culture of human skin fibroblasts from samples (biopsies) obtained on patients enrolled on NHGRI/NIH protocols. Samples of skin from individual patients are used for both biochemical analysis and genetic tests needed to better understand the basis of the patient's illness and/or as required to help define therapeutic options. 3. Extracting and storing DNA and/or RNA pellets from blood/tissue samples obtained on patients enrolled on NHGRI/NIH protocols. Methodology used should apply standard laboratory procedures that optimize and meet NIH/NHGRI requirements for high quality DNA extraction and long-term frozen storage. D. Special Handling or Handling Requirements: 1. EBV transformed lymphoblast preparation, skin fibroblast culture, and DNA/RNA preparation require specialized expertise in these skills. Methodology used should apply standard laboratory procedures that optimize and meet NIH/NHGRI requirements for high quality sample derivatives (aliquots) with capacity to maintain them for long-term frozen storage. 2. These samples acquisitions require accepting samples (blood or tissue) from patients at the NIH that have been transported under appropriate conditions, room temperature optimally within 24-hours of collection (M-F). Georgetown University TCSR will provide courier service to pick up specimens from NIH. 3. Upon request of NIH/NHGRI investigator, stored sample aliquots derived from EBV cell/tissue lines and/or DNA extraction may be pulled for transport back to primary investigator at NHGRI/NIH and/or shipped directly to a designated testing laboratory for a modest fee. 4. Capacity for long-term frozen storage maintenance of sample or their derivative aliquots for at least 1 year but capable of extending this to 5 or more years, depending on NHGRI/NIH requirements. 5. A sample tracking mechanism for NIH/NHGRI samples should incorporate NHGRI/NIH sample accession number and/or patient information as specified per protocol (protocol #, subject study ID, NIH medical record number, sample date) and outcome variables of laboratory procedure (sample type, sample date, DNA concentration/total yield, freeze/thaw #; #vials), etc. as required by NHGRI/NIH investigator. 6. Adherence to best practices that follow NIH Guidelines for Human Biospecimen Storage and Tracking within the NIH Intramural Research Program (Approve by NIH Steering Committee July 2008). 7. Request for payment must be submitted to NIH administration in a timely fashion. E. Government Responsibilities: 1. The government will package/ship and/or receive samples from patients studied under NHGRI or other NIH-IC in compliance with human biological specimens and paperwork used for standard sample request. 2. NIH/NHGRI investigator(s) may request the contractor to package, ship and/or return patient's samples and/or derived aliquots in compliance with human biological specimens. Advance notice of such requests will be coordinated via NHGRI/OCD (Iris Goode) in a timely fashion. F. Reporting Requirements and Deliverables: 1. Access to Inventory list of processed/stored samples that incorporates NHGRI/NIH sample accession number (NIH/GU) and/or patient information as specified per protocol (protocol #, subject study ID, NIH medical record number), sample date/type, and sample outcome variables (e.g., DNA concentration, volume and total yield (ug); viability of cell lines and/or # vials stored) should be made available to NHGRI/NIH. 2. Billing for these laboratory procedures/tests will not be sent to the patient, but instead will be sent directly to the appropriate administration person in NHGRI/NIH on a quarterly basis. The NHGRI agrees to pay Georgetown University TCSR within thirty days of the date of each Georgetown invoice for laboratory services. Charges for laboratory services are based on previously agreed upon fees (attached fees as of July 2014) with anticipated annual increase not to exceed 0.5%. Period of Performance: Base Year: August 2014 through July 2015 Option Year 1: 12-Months Option Year 2: 12-Months Option Year 3: 12-Months REGULATORY AUTHORITY: This acquisition is conducted under the authority of 41 U.S.C. 253(c) as set forth in FAR Part 6.302-1, only one responsible source and no other supplies or services will satisfy agency requirements. ADDITIONAL INFORMATION: Industry Classification (NAICS) Code is 541712, Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology) and the Small Business Size Standard is 500. The acquisition is being conducted under FAR Part 13, simplified acquisition procedures, therefore the requirements of FAR Part 6 B Competitive Requirements are not applicable (FAR Part 6.001). The resultant Contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 05-76 (July 25, 2014). 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 parties' bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), 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 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 August 28, 2014 and must reference synopsis number HHS-NIH-NHLBI-CSB-(HG)-2014-235-DLM, may be submitted to the National, Heart, Lung and Blood Institute, Office of Acquisition, COAC Services Branch, 6701 Rockledge Drive, Suite 6149, Bethesda, Maryland 20892-7902, Attention: Dorothy Maxwell. Response may be submitted electronically to maxwelld@mail.nih.gov. Faxes will not be accepted. Responses will only be accepted if dated and signed by an authorized company representative. "All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency."
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- Place of Performance
- Address: Contractors Location and if needed the NIH Location, United States
- Record
- SN03478067-W 20140824/140823000302-0df96d3bc446582cc9ec86b3aae66b41 (fbodaily.com)
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