SOURCES SOUGHT
Q -- NHLBI Clinical Diagnostic Testing Services
- Notice Date
- 6/30/2016
- Notice Type
- Sources Sought
- NAICS
- 541380
— Testing Laboratories
- 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
- HHSN-NIH-NHLBI-SBSS-2016-194
- Archive Date
- 7/26/2016
- Point of Contact
- Jonathan M. Lear,
- E-Mail Address
-
john.lear@nih.gov
(john.lear@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. 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 under the North American Industry Classification System (NAICS) code 541380 with a size standard $15.0M. 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 services as stated below. Background The Hematology Branch (HB) in the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH), is involved in the study of somatic mutations in patients with bone marrow failure. It has a number of NIH Internal Review Board (IRB)-approved clinical protocols focused on somatic mutations in patients that require targeted sequencing for recurrent mutations in myeloid neoplasms. These protocols cover a wide range of targeted sequencing including: chromosomal analysis/cytogenetics techniques such as karyotyping and fluorescent in situ hybridization (FISH); bone marrow aspiration and biopsy for morphology; CLL panels; additional cytogenetics (i.e. morphology, cellularity, percentage of blast cells, and chromosomal analysis by PCR); in vitro colony growth; flow cytometry; and RNA or DNA analysis. Purpose and Objectives Due to the high volume of patients received under the HB's IRB-approved clinical protocols and the vast array of testing required for each patient, the HB is unequipped to perform its diagnostic testing in-house. It, therefore, needs to outsource its testing to a CLIA-certified contractor capable of conducting a large quantity of tests in a short period of time. The contractor shall utilize NGS myeloid panels for each test, and may be required to conduct multiple tests using one panel. Tasks to be Performed The contractor shall demonstrate their capability to conduct the following tests based on clinical samples sent to the contractor by the Hematology Branch: 54 Gene Myeloid Panel by Next Generation Sequencing Cytogenetics NeoArray SNP/Cytogenetic Profile 7q Del (MDS) BTK Inhibitor acquired resistance panel IgVH Mutation analysis MYD88 Mutation analysis CLL FISH Multiple Myeloma FISH (lgH Complex) MDS FISH PML RARA t(15;17) PCR BCR-ABL by PCR (plasma based; includes log reduction and IS; p190 and p210 included) T-Cell Gene Rearrangement B Cell Lymphoma (High grade, Large B-Cell Lymphoma) Fanconi Anemia Panel Parovirus TP53 Mutation Sequencing Capability Statement / Information Sought 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: -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. -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. -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: 541380 - Testing Laboratories, with a small business size standard of $15.0M. Capability statements must demonstrate experience with similar projects and will be evaluated by the following criteria: Technical Capability The contractor must demonstrate capability of performing the tests referenced above, including Next Generation Sequencing (NGS) panel for targeted genes to evaluate myeloid disorders according to CLIA standards. Closing Statement Interested qualified small business organizations should submit a tailored capability statement for this requirement, not to exceed ten (10) 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 draft SOW. 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 Jonathan Lear, Contracting Officer, at john.lear@nih.gov in either MS Word or Adobe Portable Document Format (PDF), by July 11, 2016 at 9:00AM, EST and must reference synopsis number HHSN-NIH-NHLBI-SBSS-2016-194. All responses must be received by the specified due date and time in order to be considered. 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).
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/HHSN-NIH-NHLBI-SBSS-2016-194/listing.html)
- Place of Performance
- Address: National Institutes of Health / NHLBI, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN04168533-W 20160702/160701000054-44c1d0157e1b6a03df4f07cc3e93c2b2 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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