SOURCES SOUGHT
Q -- DNA Extraction - NIH Biospecimen Tracking and Storage
- Notice Date
- 12/20/2010
- Notice Type
- Sources Sought
- NAICS
- 622110
— General Medical and Surgical Hospitals
- 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-CSB-(HG)-2011-051-DLM
- Archive Date
- 1/19/2011
- 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
- NIH Guidelines for Intramural Human Biospecimen Tracking and Storage 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 below Engineering and Software Support Services for a Laboratory Workflow System. 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 622110 with a business size standard of $34.5 Millions. 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 the below services within 30 days after receipt of purchase order. Interested parties are expected to review this notice to familiarize yourself with the requirements of this project; failure to do so will be at your firm’s own risk. Statement of Work Background Investigators in the Division of Intramural Research for the National Human Genome Research Institute at NIH manage diverse IRB-approved human clinical protocols for a variety of rare genetic disorders that involve DNA-based molecular research analysis. As required by the IRB, any result(s) of a DNA-based molecular research study that originates from the research laboratory must be validated on human samples handled for genomic DNA extraction in a CLIA-approved (licensed) laboratory to be reportable to the patient. Inbound/outbound transportation with future & timely access to high quality genomic DNA for an estimated 200 samples per year is required. More can be added based on the customer need and the reagents/kits available for DNA extraction, that optimize quality, management, tracking and long-term storage as requested by NHGRI. Purpose NHGRI/NIH investigators require future and timely access to high quality genomic DNA extracted under CLIA-approved licensed laboratory conditions that includes the capacity for long-term storage. DNA extraction from whole blood EDTA and/or buccal cheek swab samples must be performed by standard laboratory methods/kit that optimize purity and total yield to produce high-quality genomic DNA for an estimated 200 human samples per year. The final DNA product must be prepared for long-term storage in a cryotube to withstand storage at minus 80-degree centigrade freezer conditions for minimum one or more years until requested/required by NIH/NHGRI investigator(s) for future diagnostic/validation assay(s). Contractor Requirements The Contracted laboratory shall provide for the following: 1) Inbound/outbound transportation to laboratory from NIH and/or offsite setting where sample received. Samples may be drawn at NIH-CC or obtained and shipped from offsite setting (coordinated by investigator) and transported to laboratory for DNA extraction. Upon request of NIH/NHGRI investigator, stored DNA sample(s) may be pulled for transport back to primary investigator at NHGRI/NIH and/or shipped directly to a designated testing laboratory. 2) DNA extraction: Methodology used should apply standard laboratory procedures required in a CLIA-approved setting that optimize and meet NIH/NHGRI requirements for high quality DNA extraction and long-term frozen storage. The respondent must receive whole blood in EDTA vacutainers or equivalent and/or buccal cell specimens and prepare them for DNA extraction. All reagents/DNA extraction kits, storage tubes used must optimize for purity, total yield and long-term storage. From one mL of whole blood with a normal white cell count (range of 5-10 million WBC/mL blood), the expected yield range is 15-50 ug DNA. A standard DNA extraction kit (e.g., Gentra Puregene DNA Extraction Kit) can be used for DNA extraction from whole blood EDTA and/or buccal cheek swab samples. Hydrated DNA should be assayed for purity and yield (ug) by spectrophotometry, with report available for investigator/NHGRI. The final DNA product should be prepared for long-term storage in a cryotube to withstand long-term storage in a -80 degree centigrade freezer. For 10-mL EDTA tube with normal WBC, the expected total DNA yield is approximately 150-500 ug of DNA with purity range expected 1.6-2.0. 3) 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) is required. (SEE ATTACHED FILE) 4) 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 DNA extraction (sample type, sample date, DNA concentration/total yield, freeze/thaw #), etc. as required by NHGRI/NIH investigator. Government Responsibilities • Package/ship human samples in compliance with human biological specimens and paperwork used for standard sample request. Reporting Requirements and Deliverables • Access to Inventory list of processed/stored samples with a report of sample date/type, DNA concentration, volume and total yield (ug) should be made available to NHGRI/NIH. • For each sample, minimum 1 Cryotube of DNA stored long-term (-80 degree centigrade) until requested for return. • Upon request of the NHGRI/NIH Principal Investigator or his/her designee, DNA aliquots should be returned to NIH with appropriate documentation (protocol #, sample name, accession number, sample date/type, DNA concentration, volume and total yield (ug), freeze/thaw #). Program Management and Control Requirements: Management of human samples must be in compliance with CLIA and respect confidentiality of patient information (PPI). Inspection and Acceptance Requirements • Upon arrival of sample DNA extracts/aliquots to destination, the package and contents must be undamaged. • Upon arrival of sample DNA extracts/aliquots to destination, the package and contents must be at proper temperature and include proper sample paperwork. EVALUATION CRITERIA • CLIA licensed laboratory setting (valid license)—MANDATORY CRITERIA. • The laboratory will produce high-quality genomic DNA under valid CLIA-approved license as part of this contract. • Timely access to inventory of NIH/NHGRI sample(s) that can be “pulled” upon request for transport back to primary investigator/NHGRI • Capacity for long-term frozen storage maintenance for at least 1 year but capable of extending this to 5 or more years, depending on NHGRI/NIH requirements. Interested parties should submit a tailored capability statement for this requirement, not to exceed 20 single-sided pages (including all attachments, resumes, charts, etc.) presented in single-space and using a 12-point font size minimum, that clearly details the ability to perform the aspects of the notice described above and in the attached draft statement of work. 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. 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 January 4, 2011, 7:30 AM, EST. All responses must be received by the specified due date and time in order to be considered.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/NHLBI-CSB-(HG)-2011-051-DLM/listing.html)
- Place of Performance
- Address: NIH, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN02347672-W 20101222/101220234207-b0877c552d2f916fece3b5b3ce59f798 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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