SOURCES SOUGHT
B -- Establish cell/tissue lines, with capacity for long-term frozen storage and/or high quality DNA/RNA extraction
- Notice Date
- 7/28/2014
- 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-CSB-SBSS-(HG)-2014-201-DLM
- Archive Date
- 8/20/2014
- 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
- This Sources Sought Notice (SS) is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the National Heart, Lung, and Blood Institute (NHLBI). The purpose of this SS is to identify qualified small business concerns [including Small Disadvantaged Businesses (SDB), Woman-owned Small Businesses (WOSB), Historically Underutilized Business Zone (HUBZone) Small Businesses, Veteran-Owned Small Businesses (VOSB) and Service-Disabled Veteran-owned Small Businesses (SDVOSB] that are interested in and capable of providing: 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 NIH and Georgetown University. The NHLBI does not intend to award a contract on the basis of responses nor otherwise pay for the preparation of any information submitted. As a result of this Sources Sought notice, the NHLBI may issue a Request for Quote (RFQ). THERE IS NO SOLICITATION AVAILABLE AT THIS TIME. However, should such a requirement materialize, no basis for claims against NHLBI shall arise as a result of a response to this Sources Sought notice or the NHLBI's use of such information as either part of our evaluation process or in developing specifications for any subsequent requirement. The NHLBI is seeking capability statements from all eligible small business concerns [particularly Small Disadvantaged Businesses (SDB), Woman-owned Small Businesses (WOSB), Historically Underutilized Business Zone (HUBZone) Small Businesses, Veteran-Owned Small Businesses (VOSB) and Service-Disabled Veteran-owned Small Businesses (SDVOSB)] under the North American Industry Classification System (NAICS) code 541712, Research and Development in the Physical, Engineering, and Life Sciences (except biotechnology). Based on the responses received from this SOURCES SOUGHT announcement, the proposed acquisition may be solicited as a Total Small Business Set-Aside. All eligible small business concerns responding to this Sources Sought Announcement must have the capabilities to provide goods and services as stated below. BACKGROUND: 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. OBJECTIVES: 1. 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. Long-term frozen storage of DNA, RNA and cell/tissue lines (EBV-transformed lymphoblasts, fibroblasts). 3. Provide timely access to inventory of NIH/NHGRI sample(s), which are available upon request by for transport back to NIH. 4. When/if requested, provide molecular cytogenetic and/or DNA-based testing for rare disorders in collaboration with NHGRI PIs. 5. 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%. G. Anticipated Period of Performance : Base Year: 12 Months Option Year 1: 12 Months Option Year 2: 12 Months Option Year 3: 12 Months H. Capability Statement /Information: Interested parties are expected to review this notice to familiarize itself with the requirements of this project. Failure to do so will be at your firm's own risk. The following information shall be included in the capability statement: 1. A general overview of the respondents' opinions about the difficulty and /or feasibility of the potential requirement, and any information regarding innovative ideas or concepts. 2. Information in sufficient details of the respondents' (a) staff expertise, including their availability, experience, and formal and other training; (b) current in-house capability and capacity to perform the work; (c) prior completed projects of similar nature; (d) corporate experience and management capability; and (e) examples of prior completed Government contracts, references, and other related information. 3. The respondents' DUNS number, organization name, address, point of contact, and size and type of business (e.g., 8(a), HUBZone, etc) pursuant to the North American Industry Classification System (NAICS) code: 541712, Research and Development in the Physical, Engineering, and Life Sciences (except biotechnology) small business size standard is 500. 4. Any other information that may be helpful in developing or finalizing the requirements of the potential acquisition. 5. The capability statement shall not exceed 20 single-sided pages (including all attachments, resumes, charts, etc.) presented in single-space and using a 12-point font size minimum, in either Microsoft Word or Adobe Portable Document Format (PDF), with 8-1/2 by 11 inch paper size, and 1 inch top, bottom, left and right margins. 6. All proprietary information should be marked as such. Statements should also include an indication of current certified small business status; this indication should be clearly marked on the first page of your capability statement (preferably placed under the eligible small business concern's name and address). Responses will be reviewed only by NIH personnel and will be held in a confidential manner. I. Closing Statement : All capability Statements sent in response to this SOURCES SOUGHT notice must be submitted electronically (via email) to Dorothy Maxwell, Contract Specialist, at maxwelld@mail.nih.gov in either MS Word or Adobe Portable Document Format (PDF), by August 5, 2014 7:30 AM, EASTERN TIME under Solicitation Number: HHS-NIH-NHLBI-CSB-SBSS-(HG)-2014-201-DLM. FAXES ARE NOT ACCEPTED. All responses must be received by the specified due date and time in order to be considered. This Sources Sought Notice (SS) is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the National Heart, Lung, and Blood Institute (NHLBI). The NHLBI does not intend to award a contract on the basis of responses nor otherwise pay for the preparation of any information submitted. As a result of this notice, the NHLBI may issue a Request for Quote (RFQ). THERE IS NO SOLICITATION AVAILABLE AT THIS TIME. However, should such a requirement materialize, no basis for claims against NHLBI shall arise as a result of a response to this notice or the NHLBI's use of such information as either part of our evaluation process or in developing specifications for any subsequent requirement. "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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